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1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1646 (1640 was the PSS-Lite and was closed)

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

No

1e. Today's Date

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Patient Empowerment

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Security Workgroup
We are still negotiating roles

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moehrke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkart

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not. It will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data. We believe that patient-contributed data includes, but is not limited to, patient-generated health data (PGHD).

Attachments

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

This project intersects with issues of patient consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for patients to determine who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to the intent of use by those who access the data. It also intersects with provenance tracking, in order to clearly present the source of the data and clarify whether and by whom it has been changed.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data.”
Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

3n. List of Vocabularies

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

White Paper

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5a. Is the project adopting/endorsing an externally developed IG?

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

Informative

5c. Additional Ballot Info

5d. Joint Copyright

No

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

no

6a. External Project Collaboration

6b. Content Already Developed

6c. Content externally developed?

6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors, Other

6f. Other Stakeholders

Patients and their proxies, surrogates, and caregivers.

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6g. Other Vendors

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6h. Other Providers

6i. Realm

Universal

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

7b. Sponsoring WG Approval Date

Jul 30, 2020

7c. Co-Sponsor Approval Date

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date



 Show Changes

Version

16

Modifier

Virginia Lorenzi

Modify Date

Aug 04, 2020 05:27

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1646 (1640 was the PSS-Lite and was closed)

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Security Workgroup
We are still negotiating roles

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moehrke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkart

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not. It will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data. We believe that patient-contributed data includes, but is not limited to, patient-generated health data (PGHD).

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

This project intersects with issues of patient consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for patients to determine who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to the intent of use by those who access the data. It also intersects with provenance tracking, in order to clearly present the source of the data and clarify whether and by whom it has been changed.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data.”
Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

4a. Products

White Paper

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

5d. Joint Copyright

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors, Other

6f. Other Stakeholders

Patients and their proxies, surrogates, and caregivers.

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Jul 30, 2020

Version

15

Modifier

Virginia Lorenzi

Modify Date

Aug 04, 2020 05:26

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1646 (1640 was the PSS-Lite and was closed)

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Security Workgroup

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moehrke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkart

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not. It will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data. We believe that patient-contributed data includes, but is not limited to, patient-generated health data (PGHD).

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

This project intersects with issues of patient consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for patients to determine who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to the intent of use by those who access the data. It also intersects with provenance tracking, in order to clearly present the source of the data and clarify whether and by whom it has been changed.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data.”
Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

4a. Products

White Paper

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

5d. Joint Copyright

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors, Other

6f. Other Stakeholders

Patients and their proxies, surrogates, and caregivers.

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Jul 30, 2020

Version

14

Modifier

Virginia Lorenzi

Modify Date

Aug 04, 2020 05:26

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1646 (1640 was the PSS-Lite and was closed)

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Care
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Security Workgroup

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moehrke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkart

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not. It will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data. We believe that patient-contributed data includes, but is not limited to, patient-generated health data (PGHD).

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

This project intersects with issues of patient consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for patients to determine who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to the intent of use by those who access the data. It also intersects with provenance tracking, in order to clearly present the source of the data and clarify whether and by whom it has been changed.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data.”
Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

4a. Products

White Paper

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

5d. Joint Copyright

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors, Other

6f. Other Stakeholders

Patients and their proxies, surrogates, and caregivers.

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Jul 30, 2020

Version

13

Modifier

Dave Hamill

Modify Date

Aug 03, 2020 15:02

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1646 (1640 was the PSS-Lite and was closed)

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Security Workgroup
We are still negotiating roles.

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moehrke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkart

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not. It will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data. We believe that patient-contributed data includes, but is not limited to, patient-generated health data (PGHD).

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

This project intersects with issues of patient consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for patients to determine who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to the intent of use by those who access the data. It also intersects with provenance tracking, in order to clearly present the source of the data and clarify whether and by whom it has been changed.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data.”
Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

4a. Products

White Paper

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

5d. Joint Copyright

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors, Other

6f. Other Stakeholders

Patients and their proxies, surrogates, and caregivers.

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Jul 30, 2020

Version

12

Modifier

Virginia Lorenzi

Modify Date

Jul 31, 2020 05:43

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Security Workgroup
We are still negotiating roles.

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moehrke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkart

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not. It will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data. We believe that patient-contributed data includes, but is not limited to, patient-generated health data (PGHD).

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

This project intersects with issues of patient consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for patients to determine who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to the intent of use by those who access the data. It also intersects with provenance tracking, in order to clearly present the source of the data and clarify whether and by whom it has been changed.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data.”
Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

4a. Products

White Paper

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

5d. Joint Copyright

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors, Other

6f. Other Stakeholders

Patients and their proxies, surrogates, and caregivers.

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Jul 30, 2020

Version

11

Modifier

Jan Oldenburg

Modify Date

Jul 30, 2020 19:38

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Security Workgroup
We are still negotiating roles.

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moehrke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkart

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not. WIt will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data. e believe that patient-contributed data includes, but is not limited to, patient-generated health data (PGHD).

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

This project intersects with issues of patient consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for patients to determine who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to the intent of use by those who access the data. It also intersects with provenance tracking, in order to clearly present the source of the data and clarify whether and by whom it has been changed.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data.”
Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

4a. Products

White Paper

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors, Other

6f. Other Stakeholders

Patients and their proxies, surrogates, and caregivers.

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

Version

10

Modifier

Jan Oldenburg

Modify Date

Jul 30, 2020 19:27

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Security Workgroup
We are still negotiating roles.

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moehrke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkart

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is, and is not. It will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data.

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data.”
Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for them to dictate who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to intent of use by those who access the data. It also requires provenance tracking, in order to ensure patient-defined access provision/restriction adherence, and an audit trail of who has accessed their information to be accommodated as a result of the standards defined.

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

4a. Products

White Paper

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Patients/proxies/surrogates and their caregivers

6i. Realm

Universal

Version

9

Modifier

Jan Oldenburg

Modify Date

Jul 29, 2020 15:56

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Security Workgroup
We are still negotiating roles.

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moerke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkard

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is, and is not. It will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data.

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data.”
Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for them to dictate who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to intent of use by those who access the data. It also requires provenance tracking, in order to ensure patient-defined access provision/restriction adherence, and an audit trail of who has accessed their information to be accommodated as a result of the standards defined.

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

3n. List of Vocabularies

SNOMED, LOINC, USCORE

4a. Products

White Paper

4c. FHIR Profiles Version

R4; USCore

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Patients/proxies/surrogates and their caregivers

6i. Realm

Universal

Version

8

Modifier

Jan Oldenburg

Modify Date

Jul 29, 2020 15:50

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2c. Co-Sponsor Update Periods

Monthly

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Patient Administration Workgroup

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moerke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkard

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is, and is not. It will also present the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately representing patient-contributed data.

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes: personal observations and assessments of their own health & mental status, responses to health/clinical surveys, patient-recorded vital signs, patient goals, preferences, and priorities for medical treatment (goals of care), patient health readings from devices/wearables/sensors, and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to treating care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data”.
Conduct an environmental scan to identify, and review, standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. Tthis may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for them to dictate who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to intent of use by those who access the data.
It also requires provenance tracking, in order to ensure patient-defined access provision/restriction adherence, and an audit trail of who has accessed their information to be accommodated as a result of the standards defined.

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

3n. List of Vocabularies

SNOMED, LOINC, USCORE

4a. Products

White Paper

4c. FHIR Profiles Version

R4; USCore

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Patients/proxies/surrogates and their caregivers

6i. Realm

Universal

Version

7

Modifier

Maria D. Moen

Modify Date

Jul 27, 2020 20:14

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

Monthly

2b. Co-Sponsor WG 2

Clinical Quality Information

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup
Community-Based Care & Privacy Workgroup
Orders & Observations Workgroup
Patient Administration Workgroup

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moerke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkard

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is, and is not. It will also present the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately representing patient-contributed data.

3b. Project Need

Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges.

The data represented by this information includes: personal observations and assessments of their own health & mental status, responses to health/clinical surveys, patient-recorded vital signs, patient goals, preferences, and priorities for medical treatment (goals of care), patient health readings from devices/wearables/sensors, and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion.

The presence of patient contributed data can be critical to treating care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient.

It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR.

There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address.

The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper.

It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by clinicians, EHR’s, and health information exchanges in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define the scope of what we are calling “Patient Contributed Data”.
Conduct an environmental scan to identify, and review, standards and implementation guides that exist in this space.
Define next steps for this group based on results of the scan. Tthis may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for them to dictate who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to intent of use by those who access the data.
It also requires provenance tracking, in order to ensure patient-defined access provision/restriction adherence, and an audit trail of who has accessed their information to be accommodated as a result of the standards defined.

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

3n. List of Vocabularies

SNOMED, LOINC, USCORE

4a. Products

White Paper

4c. FHIR Profiles Version

R4; USCore

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Patients/proxies/surrogates and their caregivers

6i. Realm

Universal

Version

6

Modifier

Maria D. Moen

Modify Date

Jul 27, 2020 17:38

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2b. Co-Sponsor WG

Community Based Care and Privacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

Monthly

2b. Co-Sponsor WG 2

Patient Care

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moerke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkard

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is, and is not. It will also present the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately representing patient-contributed data.

3b. Project Need

Patients and their caregivers are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges. The data represented within this information includes observations, responses to health/clinical surveys, patient vital signs, the patient's own assessment of their health status, patient goals, preferences, and priorities for medical treatment (goals of care), patient health readings from devices, wearables, and sensors, mental health status, and include their non-prescription and prescription medication history including supplements, vitamins, OTC medications, prescribed medications, side effects, and actual patterns of medication ingestion. This data can be vital for treating care team as part of understanding the patient's health condition between visits and during episodes of care, as part of understanding patterns and correlations in that critical information, and as a facilitator for empowering the collaboration between patients and their care teams. There are few standards governing how this data is collected, stored, transmitted, trended, or used, limiting the effectiveness of this genre of data. The standards that do exist are underused, potentially out-dated, not well known, and reflect different understandings of what constitutes patient-contributed data. It is important to clearly define the types of patient contributed data, understand what standards and implementation guides already exist, and develop a plan based on what is discovered to provide recommendations on a way forward to ensure patient-contributed data is communicated in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define Patient Contributed data.
Conduct an environmental scan to identify and review standards and implementation guides that exist in this space.
Define a way forward based on results of the scan (this may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of this data by patients or their caregivers/proxies, the ability to dictate who has access to it, which will touch on "trust" issues in a technical sense, and clear definition as to intent of use. It also requires provenance tracking.

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

3n. List of Vocabularies

SNOMED, LOINC, USCORE

4a. Products

White Paper

4c. FHIR Profiles Version

R4; USCore

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Patients/proxies/surrogates and their caregivers

6i. Realm

Universal

Version

5

Modifier

Jan Oldenburg

Modify Date

Jul 27, 2020 16:48

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2b. Co-Sponsor WG

Community Based Care and Privacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

Monthly

2b. Co-Sponsor WG 2

Patient Care

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

Monthly

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 3 Update Periods

Monthly

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moerke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkard

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not and what standards already exist around patient-contributed data. It will also recommend approaches and standards that need to be developed to appropriately represent patient-contributed data.

3b. Project Need

Patients and their caregivers are the closest observers of their own health and typically have information to document their health status. Data related to this information includes observations; surveys; vital signs; readings from devices, wearables, and sensors; patient's own assessment of their health status; goals, preferences, priorities for care; mental health status; and non-prescription and prescription medication history including supplements, vitamins, OTC medications, prescribed medications, side effects, and actual patterns of medication ingestion. This data can be vital for physicians to understand the patient's health condition between visits and during episodes of care, as part of understanding patterns and correlations in that critical information, and as a facilitator for empowering the collaboration between patients and their care teams. There are few standards governing how this data is collected, stored, transmitted, trended, or used, limiting the effectiveness of this genre of data. The standards that do exist are underused, potentially out-dated, not well known, and reflect different understandings of what constitutes patient-contributed data. It is important to clearly define the types of patient contributed data, understand what standards and implementation guides already exist, and develop a plan based on what is discovered to provide recommendations on a way forward to ensure patient-contributed data is communicated in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define Patient Contributed data.
Conduct an environmental scan to identify and review standards and implementation guides that exist in this space.
Define a way forward based on results of the scan (this may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of this data by patients or their caregivers/proxies, the ability to dictate who has access to it, which will touch on "trust" issues in a technical sense, and clear definition as to intent of use. It also requires provenance tracking.

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

3n. List of Vocabularies

SNOMED, LOINC, USCORE

4a. Products

White Paper

4c. FHIR Profiles Version

R4; USCore

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Patients and caregivers

6i. Realm

Universal

Version

4

Modifier

Jan Oldenburg

Modify Date

Jul 27, 2020 16:38

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moerke

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkard

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Not applicable

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not and what standards already exist around patient-contributed data. It will also recommend approaches and standards that need to be developed to appropriately represent patient-contributed data.

3b. Project Need

Patients and their caregivers are the closest observers of their own health and typically have information to document their health status. Data related to this information includes observations; surveys; vital signs; readings from devices, wearables, and sensors; patient's own assessment of their health status; goals, preferences, priorities for care; mental health status; and non-prescription and prescription medication history including supplements, vitamins, OTC medications, prescribed medications, side effects, and actual patterns of medication ingestion. This data can be vital for physicians to understand the patient's health condition between visits and during episodes of care, as part of understanding patterns and correlations in that critical information, and as a facilitator for empowering the collaboration between patients and their care teams. There are few standards governing how this data is collected, stored, transmitted, trended, or used, limiting the effectiveness of this genre of data. The standards that do exist are underused, potentially out-dated, not well known, and reflect different understandings of what constitutes patient-contributed data. It is important to clearly define the types of patient contributed data, understand what standards and implementation guides already exist, and develop a plan based on what is discovered to provide recommendations on a way forward to ensure patient-contributed data is communicated in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define Patient Contributed data.
Conduct an environmental scan to identify and review standards and implementation guides that exist in this space.
Define a way forward based on results of the scan (this may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of this data by patients or their caregivers/proxies, the ability to dictate who has access to it, which will touch on "trust" issues in a technical sense, and clear definition as to intent of use. It also requires provenance tracking.

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

3n. List of Vocabularies

SNOMED, LOINC, USCORE

4a. Products

White Paper

4c. FHIR Profiles Version

R4; USCore

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Patients and caregivers

6i. Realm

Universal

Version

3

Modifier

Jan Oldenburg

Modify Date

Jul 27, 2020 16:34

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moe

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkard

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not and what standards already exist around patient-contributed data. It will also recommend approaches and standards that need to be developed to appropriately represent patient-contributed data.

3b. Project Need

Patients and their caregivers are the closest observers of their own health and typically have information to document their health status. Data related to this information includes observations; surveys; vital signs; readings from devices, wearables, and sensors; patient's own assessment of their health status; goals, preferences, priorities for care; mental health status; and non-prescription and prescription medication history including supplements, vitamins, OTC medications, prescribed medications, side effects, and actual patterns of medication ingestion. This data can be vital for physicians to understand the patient's health condition between visits and during episodes of care, as part of understanding patterns and correlations in that critical information, and as a facilitator for empowering the collaboration between patients and their care teams. There are few standards governing how this data is collected, stored, transmitted, trended, or used, limiting the effectiveness of this genre of data. The standards that do exist are underused, potentially out-dated, not well known, and reflect different understandings of what constitutes patient-contributed data. It is important to clearly define the types of patient contributed data, understand what standards and implementation guides already exist, and develop a plan based on what is discovered to provide recommendations on a way forward to ensure patient-contributed data is communicated in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define Patient Contributed data.
Conduct an environmental scan to identify and review standards and implementation guides that exist in this space.
Define a way forward based on results of the scan (this may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of this data by patients or their caregivers/proxies, the ability to dictate who has access to it, which will touch on "trust" issues in a technical sense, and clear definition as to intent of use. It also requires provenance tracking.

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PE/Patient+Contributed+Data

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

White paper, N/A

3m. External Vocabularies

No

3n. List of Vocabularies

SNOMED, LOINC, USCORE

4a. Products

White Paper

4c. FHIR Profiles Version

R4; USCore

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6f. Stakeholders

Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

6h. Providers

Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Patients and caregivers

6i. Realm

Universal

Version

2

Modifier

Jan Oldenburg

Modify Date

Jul 27, 2020 16:27

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2d. Project Facilitator

Jan Oldenburg/Maria Moen

2e. Other Interested Parties (and roles)

Patient Empowerment Workgroup

2f. Modeling Facilitator

Not needed

2g. Publishing Facilitator

Lloyd McKenzie, John Moe

2h. Vocabulary Facilitator

Not needed

2i. Domain Expert Representative

Dave deBronkard

2j. Business Requirements Analyst

Jan Oldenburg, Maria Moen

2k. Conformance Facilitator

Not needed

2l. Other Facilitators

Virginia Lorenzi

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not and what standards already exist around patient-contributed data. It will also recommend approaches and standards that need to be developed to appropriately represent patient-contributed data.

3b. Project Need

Patients and their caregivers are the closest observers of their own health and typically have information to document their health status. Data related to this information includes observations; surveys; vital signs; readings from devices, wearables, and sensors; patient's own assessment of their health status; goals, preferences, priorities for care; mental health status; and non-prescription and prescription medication history including supplements, vitamins, OTC medications, prescribed medications, side effects, and actual patterns of medication ingestion. This data can be vital for physicians to understand the patient's health condition between visits and during episodes of care, as part of understanding patterns and correlations in that critical information, and as a facilitator for empowering the collaboration between patients and their care teams. There are few standards governing how this data is collected, stored, transmitted, trended, or used, limiting the effectiveness of this genre of data. The standards that do exist are underused, potentially out-dated, not well known, and reflect different understandings of what constitutes patient-contributed data. It is important to clearly define the types of patient contributed data, understand what standards and implementation guides already exist, and develop a plan based on what is discovered to provide recommendations on a way forward to ensure patient-contributed data is communicated in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define Patient Contributed data.
Conduct an environmental scan to identify and review standards and implementation guides that exist in this space.
Define a way forward based on results of the scan (this may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides.
Publish 1st Ballot white paper containing all of the above in January 2021.
Publish second ballot white paper in May 2021.
Publish formal version in September 2021.

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of this data by patients or their caregivers/proxies, the ability to dictate who has access to it, which will touch on "trust" issues in a technical sense, and clear definition as to intent of use. It also requires provenance tracking.

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED, LOINC, USCORE

4a. Products

FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4; USCore

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6b. Content Already Developed

Anticipated that 30% of content already exists.

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR

Version

1

Modifier

Jan Oldenburg

Modify Date

Jul 22, 2020 13:42

1a. Project Name

Patient Contributed Data Whitepaper

1b. Project ID

1640

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Payer/Provider Information Exchange

2d. Project Facilitator

Jan Oldenburg

2e. Other Interested Parties (and roles)

Maria Moen
Patient Empowerment Workgroup

2f. Modeling Facilitator

Abigail Watson; Lloyd McKenzie

2g. Publishing Facilitator

Lloyd McKenzie, John Moe

2h. Vocabulary Facilitator

Abigail Watson

2i. Domain Expert Representative

Dave deBronkard

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Debi Willis (MyPatientLink); Abigail Watson (Symptomatic)

3a. Project Scope

This project will create a white paper that explores what patient-contributed data is and is not and what standards already exist around patient-contributed data. It will also recommend approaches and standards that need to be developed to impact patient-contributed data.

3b. Project Need

Patients and their caregivers are the closest observers of their own health and typically have information to document their health status. Data related to this information includes observations; surveys; vital signs; readings from devices, wearables, and sensors; patient's own assessment of their health status; goals, preferences, priorities for care; mental health status; and non-prescription and prescription medication history including supplements, vitamins, OTC medications, prescribed medications, side effects, and actual patterns of medication ingestion. This data can be vital for physicians to understand the patient's health condition between visits and during episodes of care, as part of understanding patterns and correlations in that critical information, and as a facilitator for empowering the collaboration between patients and their care teams. There are few standards governing how this data is collected, stored, transmitted, trended, or used, limiting the effectiveness of this genre of data. The standards that do exist are underused, potentially out-dated, not well known, and reflect different understandings of what constitutes patient-contributed data. It is important to clearly define the types of patient contributed data, understand what standards and implementation guides already exist, and develop a plan based on what is discovered to provide recommendations on a way forward to ensure patient-contributed data is communicated in a robust, standard manner.

3c. Security Risk

No

3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Define Patient Contributed data.
Conduct an environmental scan to identify and review standards and implementation guides that exist in this space.
Define a way forward based on results of the scan (this may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implemntation guides.
Publish white paper containing all of the above

3f. Common Names / Keywords / Aliases:

Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3h. Project Dependencies

This project depends on clear consent for use of this data by patients or their caregivers/proxies, the ability to dictate who has access to it, which will touch on "trust" issues in a technical sense, and clear definition as to intent of use. It also requires providence tracking.

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED, LOINC, USCORE

4a. Products

FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4; USCore

5a. Project Intent

White Paper

5a. White Paper Type

Balloted Informative

5b. Project Ballot Type

Informative

6b. Content Already Developed

Anticipated that 30% of content already exists.

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR